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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 DR-T; PACEMAKER

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BIOTRONIK SE & CO. KG EDORA 8 DR-T; PACEMAKER Back to Search Results
Model Number 407145
Device Problem Misconnection (1399)
Patient Problems Twitching (2172); Discomfort (2330)
Event Date 12/18/2023
Event Type  Injury  
Event Description
Pocket revision.Patient complained of twitching at pm site and unusual timing of ra/rv leads was noted.Pocket was opened, device removed, and leads were identified as switched at header.Leads were disconnected from device, tested, and successfully reconnected using same pacemaker.Should additional information be received, this file will be updated.
 
Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
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Brand Name
EDORA 8 DR-T
Type of Device
PACEMAKER
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key18511388
MDR Text Key332873494
Report Number1028232-2024-00227
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier04035479147648
UDI-Public(01)04035479147648(17)250131
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number407145
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2023
Initial Date FDA Received01/15/2024
Supplement Dates Manufacturer Received01/16/2024
Supplement Dates FDA Received01/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age65 YR
Patient SexFemale
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